Samantha DiGrande

September 08, 2018

Alex Brill, CEO of Matrix Global Advisors, gave a presentation during the GRx+Biosims 2018 conference in Baltimore, Maryland that discussed the barriers to increased uptake of biosimilars in the United States, and how to address those issues.

September 07, 2018

In a session held at the GRx+Biosims 2018 conference in Baltimore, Maryland, Gillian Woollett, MD, DPhil, senior vice president of Avalere Health, and Michelle Lee-Bourner, head of regulatory affairs for biologics and respiratory products at Mylan, discussed experience with and expectations for biosimilar regulation.

September 06, 2018

Contrary to experience in the United States thus far, Europe has also seen what Marc-Alexander Mahl, MD, describes as “widespread support for switching biosimilars medicines under the supervision of a healthcare provider.” In fact, regulatory bodies in the EU have spoken out stating that “In our opinion, switching patients from the originator to a biosimilar medicine or vice versa can be considered safe.”

September 05, 2018

While the “FDA deservers tremendous credit to enhance and expedite [biosimilars]… there is also a reluctance or hesitation to provide a full account that while the rate of approvals has picked up, the amount of biosimilars on the market [remains low]. Approval is not a synonym for competition," said Chester Davis of the Association for Accessible Medicines.

September 05, 2018

Though biosimilars have the potential to provide a less costly option for patients, the products have not seen the uptake in the marketplace that the FDA had expected. This apprehension was reiterated in FDA Commissioner Scott Gottlieb’s comments at the meeting: “I’m not satisfied with the current state of the biologics market and biosimilars in particular.”

September 01, 2018

The Trump administration this week announced a preliminary trade deal between the United States and Mexico. Under the agreement, which looks to update the North American Free Trade Agreement, brand name drug makers will receive 10 years of exclusivity for biologics in addition to more products qualifying for this protection.

August 25, 2018

In regard to the naming guidance for biosimilars that states that each product must be given a random 4-letter suffix that is devoid of meaning, the organization encourages the FDA to reconsider.

August 24, 2018

It has now been more than 100 days since the Trump administration released the American Patients First blueprint, an effort to lower ever-increasing drug prices in the United States.

August 23, 2018

The FDA recently sent a warning letter to Kyowa Hakko Bio, the parent company of biosimilar developer Kyowa Kirin Biologics, in reference to an inspection of manufacturing plant, Hofu-shi, in Yamaguchi, Japan.

August 22, 2018

Bio-Thera Solutions, a Chinese-based biotechnology company, says that the China National Drug Administration has accepted its Biologics License Application for a potential adalimumab biosimilar, BAT1406. This is the first proposed adalimumab biosimilar to be accepted for review in China.